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Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).
The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.
The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.
The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF Therapy | Experimental | Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
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| Pelvic floor muscle training (PFMT) | Experimental | The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
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| combination of RF Therapy and PFMT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short International Consultation on Incontinence Questionnaire (ICIQ-SF) | Diagnostic Test | This is a self-administered questionnaire with four questions and a total score ranging from 0 [best] to 21 [worst] that identifies people with urinary incontinence and its impact on quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| International Consultation on Incontinence Questionnaire (ICIQ-SF) | 0 to 21 points, where higher scores indicate greater impact of incontinence | Pre - post intervention; after 3,6,12 months |
| King´s Health Questionnaire (KHQ) | 0 to 100, where 0 indicates the best quality of life and 100 the worst | Pre - post intervention; after 3,6,12 months |
| ultrasound analysis: Resting aperture (Ar) | degrees | Pre - post intervention; after 3,6,12 months |
| ultrasound analysis: Opening during exertion (Ae) | degrees | Pre - post intervention; after 3,6,12 months |
| Opening difference (Ae-Ar) | degrees | Pre - post intervention; after 3,6,12 months |
| MUSCULAR STRENGTH | defined as the ability of tissue to generate tension based on its contractile capacity, being the best of three attempts to contract, assessed using the modified OXFORD scale | Pre - post intervention; after 3,6,12 months |
| Function of the pelvic floor muscles | The best of the three attempts is selected, graded as follows: 0 = no contraction, 1 = partial contraction, 2 = contraction of the pelvic floor muscles + contraction of related muscles, 3 = isolated contraction of the Pelvic floor muscles |
| Measure | Description | Time Frame |
|---|---|---|
| age (years) | baseline | |
| BMI (Body mass index) | kg / m² | baseline |
| smoke |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ceu Cardenal Herrera University | Elche | Alicante | 03204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42354475 | Derived | Trana-Serrano JP, Orts-Ruiz C, Montero-Navarro S, Zamora-Streber A, Ramirez Rivera MJ, Garita Redondo O, Molina-Paya FJ, Fluxa-Juan L, Sanchez-Mas J, Salar-Andreu C. Second-Generation Radiofrequency and Targeted Therapeutic Exercise for Stress Urinary Incontinence Due to Urethral Hypermobility: A Study Protocol. Healthcare (Basel). 2026 Jun 9;14(12):1616. doi: 10.3390/healthcare14121616. |
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The data associated with this paper will be available in the Zenodo repository
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 14, 2026 |
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| Experimental |
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
|
|
| King's Health Questionnaire (KHQ) | Diagnostic Test | The KHQ is a self-administered instrument specifically designed to assess quality of life in women with UI. It consists of 21 items distributed across 9 dimensions: perception of overall health (1 item), impact of UI (1 item), limitations in daily activities (2 items), physical limitations (2 items), social limitations (2 items), personal relationships (3 items), emotions (3 items), sleep/energy (2 items), and severity of UI (5 items). The score range for each dimension is from 0 (lowest impact of UI and therefore best quality of life) to 100 (highest impact, worst quality of life). This questionnaire provides an overall value for the quality of life of the patient with UI (Overall Score-OS) and another specific value for each dimension on a scale with the following range: 0: Best possible quality of life - 100: Worst possible quality of life. |
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| Ultrasound evaluation | Diagnostic Test | A two-dimensional (2D) ultrasound system with B-mode capability and cine-loop function, a 3.5 to 6 MHz curved convex probe transducer, was used for the perineal image. The examination will be performed in the dorsal lithotomy position, with the hips flexed and slightly abducted and the heels placed close to the buttocks, or in a standing position if necessary. |
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| Sandvik Severity Index | Diagnostic Test | It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI. |
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| Oxford's scale | Diagnostic Test | The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale. |
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| Biofeedback | Diagnostic Test | Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O) |
|
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| Pre - post intervention; after 3,6,12 months |
| STATIC MUSCLE STRENGTH | the ability to maintain optimal contraction (isometric, tonic fibers) for as long as possible, measuring the seconds until fatigue sets in. ORDER: "contract and hold," taking the average of the three assessments. | Pre - post intervention; after 3,6,12 months |
| Fatigability or Dynamic Endurance | maximum number of contractions in a unit of time, taking 10 seconds as the average. ORDER: "contract as many times as possible and at the highest speed," with the measurement being the average of the three assessments. | Pre - post intervention; after 3,6,12 months |
| Oxford's Scale | allows the contractile capacity of the pelvic floor muscles to be assessed. It scores from 0 to 5, as follows: if there is no contraction, it is scored as 0; if the contraction is very weak, it is scored as 1; if the contraction is weak, it is scored as 2; if the contraction is moderate/with tension/and sustained, it is scored as 3; if the contraction is good and maintains tension with resistance, it is scored as 4; and if the contraction is strong and maintains tension against a resistant force, it is scored as 5. | Pre - post intervention; after 3,6,12 months |
| Sandvik Severity Index | It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI. | Pre - post intervention; after 3,6,12 months |
yes/no |
| baseline |
| alcohol consumption | yes/no | baseline |
| drug use | yes/no | baseline |
| full-term pregnancies | Number | baseline |
| natural childbirth | yes/no | baseline |
| cesarean sections | yes/no | baseline |
| tear | yes/no | baseline |
| abortion | yes/no | baseline |
| episiotomy | yes/no | baseline |
| Jan 14, 2026 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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